| Inclusion Criteria: | 1) Histopathologically proven diagnosis of glioblastoma. Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.
2) Patients must have at least 1 block of tumor tissue available for submission to the central pathologist for analysis of gene expression status by QRT-PCR; there must be at least 1 cm^2 of tumor from the block when cut on a slide: fresh frozen tumor tissue acquisition is also encouraged, but not required. Unstained slide submission without a block submission is not acceptable for study entry.
3) Diagnosis must be established by open biopsy or tumor resection. Patients who have only had a stereotactic biopsy are not eligible..
4) The tumor must have a supratentorial component.
5) Patients must have recovered from the effects of surgery, postoperative infection, and other complications before study registration.
6) All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
7) A diagnostic contrast-enhanced MRI or CT scan (if MRI is contraindicated) of the brain must be performed postoperatively in the period between surgery and initiation of radiation therapy.
8) Therapy must begin </=5 weeks after the most recent brain tumor surgery.
9) History/physical examination within 14 days prior to study registration.
10) Neurologic examination within 14 days prior to study registration.
11) Documentation of steroid doses within 14 days prior to study registration and stable or decreasing steroid dose within 5 days prior to registration.
12) Karnofsky performance status of >/= 60.
13) Age >/= 18 years.
14) Patients with well-controlled hypertension are eligible (systolic blood pressure of </= 140 mgHg or diastolic pressure </= 90 mgHg).
15) CBC/differential obtained within 14 days prior to study registration, with adequate bone marrow function as defined below: Absolute neutrophil count (ANC) >/= 1500 cells/mm^3; Platelets >/= 100,000 cells/mm^3;Hemoglobin >/= 10 g/dl.
16) Adequate renal function, as defined below: Serum creatinine </= 1.7 mg/dl within 14 days prior to study registration
17) Adequate hepatic function, as defined below: Bilirubin </= 2.0 mg/dl within 14 days prior to study registration; ALT </= 2 x upper limit of normal range (ULN) within 14 days prior to study registration; AST </= 2 x ULN range within 14 days prior to study registration
18) Fasting cholesterol < 300 mg/dL (9.0 mmol/L) and fasting triglycerides < 2.5 times ULN
19) INR < 1.5 or a PT/PTT within normal limits for patients not on anti-coagulation treatment
20) Patients receiving anti-coagulation treatment with an agent such as warfarin or low molecular weight heparin may be allowed to participate with the following criteria: For patients on prophylactic anticoagulation therapy (low-dose warfarin): INR level < 1.5; Patients on prophylactic dose or full dose low molecular weight heparins are eligible provided that the patient has no active bleeding or pathological condition that carries a high risk of bleeding;
21) (20. continued) Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met: (a) Patient has an in-range INR (usually between 2-3) on a stable dose or oral anticoagulant or on a stable dose of low molecular weight heparin. (b) Patient has no active bleeding or pathological condition that carries a high risk of bleeding.
22) If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member.
23) For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide
24) Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least six months after the last administration of sorafenib or temozolomide. |